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Claims about pulsed radiofrequency for back pain and sciatica are premature

Pulsed radiofrequency relieves acute back pain and sciatica

Our Review Summary

The main problems with this news release promoting an abstract from a radiology meeting are that it fails to mention the research is unpublished, and there are significant limitations which may well preclude a headline such as: “Pulsed Radiofrequency (pRF) Relieves Acute Back Pain and Sciatica.”

The touted benefits of pRF (pulsed energy applied to nerve roots of the spine by a probe) noted in this study are based on difficult-to-reproduce patient questionnaires, and framed with language that makes it very difficult for readers to place in an understandable context.

Although alternatives are nicely covered — benefits, costs, availability, and potential harms of the outpatient probe procedure are not.

We also reviewed a HealthDay news story about the study. Both the story and news release would have been improved with more discussion about cost, benefits and harms.

 

Why This Matters

Chronic back pain that does not respond to conservative treatment, and sometimes includes shooting pain into the buttocks and leg (sciatica), is difficult to treat, a leading cause of disability, and poses a huge economic burden to both individuals and the health care system.

Although the search for treatments that are “minimally invasive” are well-intentioned and much needed, this catchphrase can be quite misleading. As we’ve written before, many readers erroneously equate “minimally invasive” with more advanced and effective, and involving fewer complications and recovery time. Rather than prey on this notion, releases should clarify if procedures touted in this way even come close to meeting such expectations.

Many back patients have very straightforward questions they need answered: Do I need surgery? If not, what are my alternatives? How effective are those alternatives? What are the benefits vs. risks involved? What will it cost me? Not answering those questions clearly (or making it clear if the answers are unknown) does readers a disservice.

Back pain creates tremendous personal, family and economic burdens. In the majority of individuals, the source of the pain cannot be identified, and undoubtedly there are many different causes of back pain. If the source of pain in any individual can be identified accurately, specific interventions may be able to be developed to treat that subset of patients resulting in improved quality of life for those individuals and less economic burden.  But it’s also important to keep in mind that in the vast majority of individuals, the pain resolves spontaneously without any residual disability.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Costs are not included.

Comparing the cost of the three treatment options mentioned in the release — CT-guided pRF, CT-guided steroid injections, and lumbar disk surgery — would have been appropriate and helpful.

An assumption is made that the cost of this procedure is less than a surgical intervention. This is often not the case, and “minimally” invasive approaches can cost more.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The news release reports these 1-year outcomes:

  • greater overall improvements in pain and disability scores (with pRF vs. steroid injections)
  • “faster” relief of leg pain.
  • a “rate of perceived recovery” that was faster
  • a “probability of perceived recovery” = 95% at one year follow-up for pRF (vs. 61% for steroid injection only)

The terminology here is very vague. It would have been helpful to clarify what the rate and probability of “perceived recovery” mean, and how they’re measured.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release leads with a phrase we find problematic: “minimally invasive.” For many readers this connotes a quick, “safe and effective” intervention as mentioned in the release. But “minimally invasive” can potentially have more complications than a prior “more invasive” approach.

No instrumentation close to the spine or its nerve roots is risk-free. Nerve damage and infection are two potential complications that should have been mentioned.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

This is a major weakness of the news release because the following key points are omitted:

  1. This is preliminary, unpublished data that has not been peer-reviewed.
  2. The outcomes are based on patient questionnaires — which can be unreliable, difficult to reproduce, and subject to bias.
  3. The lead author touts the results as “superior” to usual care strategies and “without adverse effects” but no scientific data are provided to support these claims.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering.

Chronic lower back pain is not only very common and very difficult to treat, but it’s also one of the leading causes of disability and missed work days.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

Study funding is not included.

A review of the meeting abstract reveals no conflicts of interest disclosed by the seven authors.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The news release defines what alternatives are available for acute back pain with sciatica, including pain medications, cortisteroids and surgery. It details outcomes in patients treated with steroid injections compared with pRF.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

It’s not made clear for readers if this is an experimental therapy, or if it is widely available.

The procedure is, in fact, a refined technique of an older procedure.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The release doesn’t explain what’s novel about the research.

The rPF procedure has been used extensively for a variety of chronic pain conditions for years.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

The headline is misleading. The source of back pain is usually unknown and even if an imaging study demonstrates a disc herniation it is usually not the identifiable cause of the pain. The title could lead people to seek treatment for their imaging finding but not resolve their pain.

It’s unjustified to make broad claims as found in the headline based on unpublished data.

Total Score: 2 of 10 Satisfactory

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